Baxter receives EC approval for Celvapan H1N1 pandemic flu vaccine

14 October 2009

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Baxter International Inc. (NYSE: BAX) has announced that the
European Commission (EC) has granted marketing authorization for Celvapan H1N1 pandemic vaccine using Baxter’s Vero cell technology.

Celvapan H1N1 is the first cell culture-based and non-adjuvanted
pandemic influenza vaccine to receive marketing authorization in the
European Union.

Baxter continues to deliver vaccine to national public health
authorities that have agreements with the company. Initial quantities of
vaccine have already been received by a number of countries, including
the UK and Ireland, for use in their national vaccination programs.

Baxter is confirming the safety and immunogenicity of Celvapan H1N1
in clinical trials and will supplement the licensure post-approval with
data from its ongoing clinical trial program. Preliminary safety data
from Celvapan H1N1 clinical trials in adults age 18 and older indicate
the vaccine is well tolerated. The observed systemic and local reactions
are similar to those generally experienced after vaccination with
licensed seasonal influenza vaccines.

Immunogenicity data from the first vaccination in adults will be
submitted to the European Medicines Agency within days. The current
dosing schedule, as specified in the EMEA mock-up licensure for Celvapan
using another virus strain, calls for two 7.5 µg doses of vaccine to be
given 21 days apart. Baxter expects the data from the trial of healthy
adults to indicate whether a single dose may be possible for Celvapan
H1N1. This study will also determine whether a lower dose, 3.75µg, is
sufficient to induce the necessary immune response.

About Baxter's pandemic vaccine development

Earlier this year, the EMEA granted mock-up licensure for Celvapan
using a different strain with pandemic potential, which was tested in
five completed clinical trials worldwide in more than 1,300 people. In
addition, more than 3,500 people have been vaccinated using the same
strain during an ongoing Phase III study.

Mock-up licensure is a regulatory pathway for pandemic vaccines that
was created by the EMEA in 2004. This pathway allows for the
development, evaluation and licensure of a company’s pandemic candidate
vaccine using an available influenza strain that has the potential to
cause a pandemic. Once a pandemic is declared and the influenza virus
strain causing the pandemic is identified, the mock-up licensure allows
for fast track approval of a pandemic vaccine containing the actual
pandemic strain.

Baxter received the H1N1 strain for testing and evaluation from the
US Centers for Disease Control and Prevention (a WHO Collaborating
Center) in early May. The company then undertook pre-production testing
and evaluation of the virus strain to assess its growth characteristics
in the company’s proprietary Vero cell culture technology.

Baxter initiated commercial production in early June, and made its
first commercial product within 12 weeks of receipt of the virus. The
company produces bulk Celvapan H1N1 vaccine at its large-scale
commercial facility in Bohumil, Czech Republic, and then sends the
vaccine to Vienna, Austria for the final formulation, fill and finish
before distribution. Baxter completed production of the first batches of
Celvapan H1N1 vaccine in late July and initiated its first delivery
within two weeks. The company continues to deliver vaccine on an ongoing
basis to national public health authorities.

Baxter initiated its license application for Celvapan H1N1 in July
based on the EMEA published guidelines for pandemic vaccine marketing
authorization. The company conducted rigorous testing of the H1N1 based
vaccine and submitted additional data for vaccine development, product
quality and manufacturing processes specific to that strain. Other
non-EU countries may choose to evaluate the company’s EMEA submission
and licensure as the basis for their national health authority’s
authorization for use of the vaccine.

The company is conducting two randomized trials in 400 healthy adults
age 18 and over and in 400 children and adolescents to supplement the
licensure post-approval with appropriate clinical data. These trials are
evaluating the safety and immunogenicity of the vaccine at dose levels
of 7.5µg and 3.75µg. Once countries initiate national vaccination
programs using Celvapan H1N1, Baxter will also conduct a large-scale
observational study in 9,000 people of different age groups, including
children.